ANDA stands for which of the following?

• A. Abbreviated Drug Application
• B. Abbreviated New Drug Application
• C. Accelerated New Drug Approval
• D. Agency for Drug Applications

Answer: (B)

ANDA stands for Abbreviated New Drug Application, the pathway used in the United States to obtain approval for generic drugs. It’s labeled “abbreviated” because, instead of repeating the full suite of clinical trials required for a new drug, the sponsor must demonstrate that the generic is bioequivalent to the reference branded product and meets appropriate quality standards. This includes showing the same dosage form, strength, route of administration, labeling, and manufacturing controls, with evidence that it behaves the same way in the body. Once the reference product’s patent and exclusivity protections have expired, a sponsor can use this route to bring the generic to market. The other options don’t fit: Abbreviated Drug Application omits the crucial “New” aspect; Accelerated New Drug Approval refers to a different regulatory path for certain innovative therapies, not generics; Agency for Drug Applications is not a real regulatory term—the FDA handles drug approvals.